Europe – Evaluation of anticancer medicinal products in man : Concept paper on the revision of the guideline

This concept paper introduces revision 6 proposing amendments and add-ons to the last version of the guideline on the evaluation of anticancer medicinal products in man. It is also proposed to amend the title to “the guideline on the clinical evaluation of anticancer medicinal products in man” (currently EMA/CHMP/205/95 Rev.5). The upcoming revision 6 proposes a review of the concepts related to biomarkers, which are increasingly used to define malignant diseases and develop new treatment strategies, improve description of the regulatory standards relevant for rare cancers and additional minor amendments to
other sections…